BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20081408 · Received August 27, 2024

    Report

    Report Number
    3026007685-2024-00005
    Event Type
    Death
    Date Received
    August 27, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE INVESTIGATION, THE ROOT CAUSE FOR LACK OF PATIENT DETECTION WITH THE CMPT-00144 DEVICE ISDUE TO AN INCOMPLETELY INSTALLED ELECTRODE PAD CARTRIDGE DURING THE EMERGENCY. IT WAS IDENTIFIED THAT THE CMPT-00144 DEVICE REQUIRED HIGHER THAN EXPECTED FORCE TO INSTALL THE ELECTRODE PAD CARTRIDGE, LIKELY DUE TO EXCESSIVE GLUING. ELECTRICAL TESTING DID NOT REVEAL ANY ANOMALIES IN BEHAVIOR OF THE DEVICE AND THERE WERE NO ELECTRICAL DEFICIENCIES IDENTIFIED IN THE AED ELECTRONICS THAT COULD IMPACT PATIENT DETECTION. FROM MECHANICAL TESTING, IT APPEARS THAT THE FORCE REQUIRED TO INSTALL THE CARTRIDGE IN THIS DEVICE IS GREATER THAN PREVIOUSLY MANUFACTURED DEVICES AND RESULTED IN THE CARTRIDGE NOT BEING FULLY INSTALLED IN THE DEVICE AT THE TIME OF THE EMERGENCY USE. IF THE CARTRIDGE WAS NOT FULLY INSTALLED, THE DEVICE COULD HAVE INITIALLY DETECTED THE PATIENT, BUT A SLIGHT MOVEMENT OF THE DEVICE MAY HAVE DISRUPTED THE ELECTRICAL CONNECTION BETWEEN THE PADS AND AED RESULTING IN THE PATIENT NOT BEING DETECTED. THIS ROOT CAUSE APPEARS TO BE MOST LIKELY HOWEVER, BECAUSE THE PAD CARTRIDGE USED DURING THE INCIDENT WAS NEVER RETURNED FOR INVESTIGATION IT IS UNKNOWN IF IT MAY HAVE CONTRIBUTED TO A PATIENT NOT BEING DETECTED.

    Description of Event or Problem · 0

    BELOW IS AN EMAIL THAT WAS FORWARDED FROM (B)(6). (B)(6), OFC. (B)(6) REPORTED AN ISSUE WITH HIS AVIVE AED ON A RECENT CALL. HE PLACED THE PADS ON THE PATIENT'S CHEST AND THE AED SAID PATIENT DETECTED, AS IT IS SUPPOSED TO. HOWEVER, A COUPLE SECONDS LATER, IT SAID, "PATIENT NOT DETECTED" AND KEPT GIVING INSTRUCTIONS ABOUT PAD PLACEMENT. THE AED NEVER ENDED UP ANALYZING THE PATIENT OR DELIVERING A SHOCK. I REVIEWED HIS BODY CAM FOOTAGE AND THE ONLY THING I NOTICED WAS THAT THE PADS SEEMED SLIGHTLY CLOSER THAN USUAL ON THE PATIENT'S CHEST. DO YOU MIND RUNNING THIS ISSUE PAST YOUR CONTACT AT AVIVE AND SEE IF HE HAS ANY IDEAS AS TO WHAT CAUSED THE ERROR? I CAN SEND OVER A SCREENSHOT OF THE BODY CAM FOOTAGE TO SHOW WHAT I MEAN ABOUT PAD PLACEMENT (AS LONG AS THAT WOULD NOT VIOLATE ANY OF OUR DISCLOSURE POLICIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464626 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death